Measurement of Pituitary Volume and Hormonal Changes in Patients With Post-traumatic Stress Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Cedars-Sinai Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT00815204
First received: December 24, 2008
Last updated: June 21, 2011
Last verified: December 2008
  Purpose

Approximately, post-traumatic stress disorder (PTSD) occurs in 8% of the adult population over time. Exposure to traumatic events increases the risk of poor physical health and often leads to disability. The biology of PTSD is continually being explored in order to help find better treatments for this debilitating disorder. In our study, we propose to further our understanding of PTSD. Prior research has found that patients with PTSD have changes in the stress hormone pathway. In this pathway, there is release of certain hormones from the pituitary gland in the brain that feed into the blood stream and tell the adrenal gland to produce stress hormones.

The pituitary is a gland located at the base of the brain which controls the hormones in the body, including the stress hormones. Research in other psychiatric disorders has found changes in the pituitary volume along with changes in the hormones. This has not been investigated yet in PTSD. Therefore, we propose in our study to measure pituitary volume in people with PTSD and look at the changes in the stress hormone pathway. Moreover, we will investigate whether other hormones are affected by PTSD. In this way, we can further our understanding of the the biology of PTSD and help develop new therapies which can intervene through the hormonal system.


Condition Intervention
Posttraumatic Stress Disorder
Procedure: MRI of the pituitary
Procedure: DEX/CRH test

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Measurement of Pituitary Volume and Hormonal Changes in Patients With Post-traumatic Stress Disorder

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Pituitary volume [ Time Frame: On second day of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cortisol and ACTH levels on DEX/CRH test [ Time Frame: On day 1 and day 2 of study test ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Will be collecting blood to check for hormone levels


Estimated Enrollment: 30
Study Start Date: May 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
posttraumatic stress disorder Procedure: MRI of the pituitary
Patients will undergo a T1 weighted MRI of the pituitary to measure pituitary volume
Other Names:
  • MRI
  • Pituitary
Procedure: DEX/CRH test
Subjects will have blood drawn for baseline ACTH, cortisol, and other hormones and then undergo a DEX/CRH test. Will then measure ACTH and cortisol on test.
Other Names:
  • Dexamethasone
  • CRH
history of trauma exposure but no PTSD Procedure: MRI of the pituitary
Patients will undergo a T1 weighted MRI of the pituitary to measure pituitary volume
Other Names:
  • MRI
  • Pituitary
Procedure: DEX/CRH test
Subjects will have blood drawn for baseline ACTH, cortisol, and other hormones and then undergo a DEX/CRH test. Will then measure ACTH and cortisol on test.
Other Names:
  • Dexamethasone
  • CRH
healthy controls Procedure: MRI of the pituitary
Patients will undergo a T1 weighted MRI of the pituitary to measure pituitary volume
Other Names:
  • MRI
  • Pituitary
Procedure: DEX/CRH test
Subjects will have blood drawn for baseline ACTH, cortisol, and other hormones and then undergo a DEX/CRH test. Will then measure ACTH and cortisol on test.
Other Names:
  • Dexamethasone
  • CRH

Detailed Description:

Lifetime prevalence of post-traumatic stress disorder (PTSD) is estimated at 8%. Exposure to traumatic events increases the risk of poor physical health, and chronic PTSD often leads to disability. The pathophysiology of PTSD is continually being explored in order to help find better treatment modalities for this debilitating disorder. Proposed mechanisms for the altered stress axis in PTSD include changes at the level of the pituitary. Though the pituitary stress hormone axis has been explored, no work has been done to evaluate for changes in the pituitary volume in response to these changes in the stress axis in PTSD. We have designed a study which will assess for differences in pituitary volumes. We will compare volumes in patients with PTSD, non-PTSD subjects who have had a history of trauma, and healthy controls. We will test the HPA axis through the dexamethasone/CRH test, a standardized diagnostic test, and correlate the findings with changes in the pituitary volume. Moreover, we will assess for changes in other endocrine axes and proteins.

We propose to further our understanding of PTSD by establishing a direct link between structure and function. By establishing these links in structure and function, novel therapies which can intervene through the endocrine system may prove to be of benefit in treating PTSD

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects will be recruited from psychiatric clinics at Cedars-Sinai and at the West Los Angeles VA Center

Criteria

Inclusion Criteria:

  • Age 18-80
  • history of PTSD

Exclusion Criteria:

  • Uncontrolled medical or psychiatric conditions Liver or kidney disease Use of anti-depressants or ketoconazole Use of steroids within a year of the study Use of drugs of abuse Pregnancy or nursing Metal implants Low testosterone states A history of head bleeds or pituitary tumors
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00815204

Contacts
Contact: Odelia Cooper, MD 3104232830 coopero@cshs.org

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: William Gellepis    310-423-3395    william.gellepis@cshs.org   
Principal Investigator: Odelia Cooper, MD         
Sub-Investigator: Shlomo Melmed, MD         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Study Director: Shlomo Melmed, MD Cedars-Sinai Medical Center
Principal Investigator: Odelia Cooper, MD Cedars-Sinai Medical Center
  More Information

No publications provided

Responsible Party: Shlomo Melmed/Senior Vice President of Academic Affairs, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00815204     History of Changes
Other Study ID Numbers: 13353
Study First Received: December 24, 2008
Last Updated: June 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
PTSD
HPA axis
Pituitary volume

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Dexamethasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 28, 2014